IVAC Blog

September 12, 2013 was no ordinary day for me as a graduate research assistant working on the mobile solutions for immunization (m-SIMU) trial. Instead of going out to the field to visit a health facility or working on our SMS appointment reminder system, I found myself in a room with live music, laughter, dancing, and over 100 community advisory board members and village chiefs. This was the scene of the m-SIMU public randomization ceremony, a true moment of “public health in practice". It was an amazing sight to witness, as several months of preparation and hard work had gone into ensuring the successful execution of this event. For me, it was a gratifying experience to see the community so excited for the start of the m-SIMU trial.  

The community approval of the public randomization ceremony meant that the m-SIMU trial was ready to begin. m-SIMU is a village-randomized controlled trial to assess the impact of short message services (SMS) reminders and cash incentives to improve childhood immunization coverage rates and timeliness in Siaya County, Western Kenya. It will add to the existing evidence base for mHealth and conditional cash transfers, two novel strategies in the field of public health.

The project will aim to enroll about 2,000 infants under the age of four weeks across 152 villages in Western Kenya. These children will be followed over 12 months during which time their vaccination status for routine EPI immunizations will be documented. The 152 villages are assigned to one of four arms:

1. Control
2. SMS reminders
3. SMS reminders + 75 Kenyan Shillings (Ksh), which is just under USD 1, for every vaccine dose received on time
4. SMS reminder + 200 Ksh (approximately USD 2.50) for every vaccine dose received on time.

The trial is a collaboration between IVAC and Kenya Medical Research Institute/Centers for Disease Control and Prevention (KEMRI/CDC).

The public randomization ceremony was held to assign 152 villages to the four study arms. We chose to do the randomization publicly to assure the community that the process for allocating villages to study arms was fair.  We also saw the ceremony as an important way to boost community morale and raise excitement and acceptance of the m-SIMU trial.

Dustin Gibson, m-SIMU co-investigator and PhD candidate at the Johns Hopkins Bloomberg School of Public Health, with the community advisory board members after selecting villages for each trial arm

Preparation for the randomization ceremony involved using our epidemiologic toolbox and some creative thinking. We worked with Dr. Larry Moulton, Professor and Biostatistician at Johns Hopkins Bloomberg School of Public Health, to identify randomization sequences that adjusted for confounders. The next two steps necessary for assigning villages to the study arms were to randomly pick one of the sequences and then randomly assign each of the groups to a study arm. These steps were to occur during the public randomization ceremony and the selection would be done by community members themselves. During the ceremony, the community members enjoyed the suspense and excitement that came along with selecting the sequences, as they had to draw balls out of a cloth sack. 

The randomization ceremony was a unique approach to engage the community and really helped to make the m-SIMU trial “come alive”. While we had previously attended meetings to inform the community members about the m-SIMU trial, in some ways, it felt as though we were just another KEMRI/CDC study to them. The ceremony made a memorable impression on the community and the m-SIMU trial had distinguished itself in a positive light. One of my favorite memories from that day was when a community advisory board member approached and thanked us for including her community in the trial and for holding the ceremony. 

Nisha and the field supervisor, Jully Odhiambo, at the public randomization ceremony

As a student and a young public health professional, being able to be part of the community mobilization process and the randomization ceremony was an extremely important learning experience. Gaining community approval and investing the time to inform and engage community members are crucial to the success of any intervention or trial. The effort involved here should not be underestimated. From debating over the right size of the cloth sack to rehearsing the explanation of the randomization process – we contemplated and planned every detail in advance. I will definitely stick to these principles as I begin my career in public health.

The m-SIMU trial officially started on October 14, 2013 and has now enrolled over 900 children.  

By Jillian Murray

 “Influenza… what about HIV? That’s what people are dying from here.”

These are the words I heard in countless conversations while working on an influenza research project in South Africa last summer. Nearly every time I mentioned I was working on a public health research project I was met with a chorus of “ohhh HIV.” After explaining that I was, in fact, researching influenza, the conversation usually shifted to wondering why I would focus on something other than HIV.

I remember leaving some people unconvinced of the importance of studying respiratory diseases. Many had an emotional connection to HIV and recounted stories of people they knew dying of AIDS, but were unable to recall someone who died of influenza. In some populations, this acute awareness of the devastation of the HIV/AIDS epidemic has led to an ideology where an HIV diagnosis is mutually exclusive of other diseases.

Jillian Murray and a colleague in the Soweto township in Johannesburg during interviews for a health survey.

I found it interesting to witness the distinct hierarchy in the perceived importance of certain diseases. Influenza causes annual worldwide epidemics and can be a life-threatening complication of many other diseases, but because many people rank it’s severity slightly above the common cold, it is often assumed to be rather harmless. This is not only true in settings where there are other high priority communicable diseases, but is a common perception in North America as well.

The true burden of influenza is not well described in many developing countries. However, the burden is expected to be higher in developing compared to developed countries because of underlying factors that contribute to greater severity of disease – factors like crowding, low birth-weight, malnutrition and HIV, among others. In contrast to developed countries where the burden is primarily in the elderly population, these socio-economic factors play a role in broadening the demographic that is most at-risk for severe influenza in South Africa.

A better understanding of the burden of influenza is important for pandemic planning and more effective distribution of vaccine supply. While in South Africa, I worked under the supervision of Daniel Feikin, IVAC’s Director of Epidemiology. With the help of researchers at the National Institute of Communicable Diseases, we used a statistical model that adjusted for influenza risk factors between different provinces to estimate the burden of severe influenza at the provincial and national levels.

As it turned out, my work was very much related to HIV, which severely compromises the immune systems of those affected. There is evidence that HIV-positive individuals suffer a much greater mortality rate from influenza than HIV-negative individuals and that the risk for acquiring influenza in HIV-positive individuals is much greater than in HIV-negative individuals. A high prevalence of HIV, such as exists in South Africa, can cause the burden of influenza to be much greater than you would expect in a population with low HIV prevalence. For these reasons, HIV became one of the most influential risk factors for which we controlled in our study.

An important aim of the burden study in South Africa was to guide public health authorities in the country on how their policies regarding influenza vaccination can better meet the needs of their population. The HIV prevalence in South Africa, while varied between provinces, averages 17% in the 15-49 age group. It is crucial for public health officials to understand the disproportionate risk people in this age cohort have of developing severe influenza infections, and to develop policies and programs accordingly.  

My conversations about why I was researching influenza were both valuable learning and teaching opportunities for me. The devastating HIV epidemic in South Africa is inextricably linked to increased susceptibility of its population to concomitant infections, such as severe cases of influenza. Therefore, it is important that discussions of HIV and influenza overlap in order to reinforce in the public’s mind the relationship these diseases have with each another. I hope I was able to play a role – however small – in increasing this understanding.

Jillian Murray is a second year Master of Science in Public Health (MSPH) student in the Global Disease Epidemiology and Control program at Johns Hopkins Bloomberg School of Public Health.

By Lois Privor-Dumm

It’s not often that themes for meetings are really meaningful, but the RISE (Results, Innovation, Sustainability and Equity) theme of the GAVI Partners’ Forum last week in Tanzania really rang true to the work that is being done. I felt proud to be a part of the progress being made and for IVAC’s role in advancing the four RISE principles. 

Lois Privor-Dumm, MIBS

For example, last week IVAC had the opportunity to continue progress on an ongoing project related to supply chain and decision-making innovation by following up with many partners who attended a primary container roundtable we organized in May 2012 where we reviewed the available evidence on vaccine containers and developed a framework for improving decision making. Building on the discussions from that meeting, we met at the Forum to review an exercise of the HERMES (Highly Extensible Resource for Modeling Supply-chains) modeling system that Bruce Lee and his team from University of Pittsburgh conducted in Benin along with in-country partners including AMP. Colleagues from GAVI, the Bill & Melinda Gates Foundation, UNICEF, WHO, John Snow, Inc., Clinton Health Access Initiative, manufacturers and others joined us at the crack of dawn to review the results of the Benin pilot and provide feedback on the exercise. 

On the surface, decisions about which type of vaccine container to use don’t seem that complicated, but implications are far reaching. We discussed the more obvious implications including changes in procurement, logistics costs and cold chain space, which are relatively well understood. We also took the conversation a bit further, looking at the effects of vaccine hesitancy and availability on coverage. For example, if a health center has large vial sizes and only one or two children are scheduled to visit that day, a health worker may hesitate to open a new vial, thus missing a vaccination opportunity and reducing coverage. On the other hand, if the health worker does open the vial, the rest of the vaccine may be wasted, which could reduce vaccine availability for children who visit the center in the future. The complexities of these decisions become clear after a closer look.

We also discussed the safety considerations that come into play, particularly with new products coming down the pike. We agreed on the importance of bringing visibility to competing tradeoffs to ultimately help countries, donors and manufacturers make better decisions. Highlighting the impact of container decisions can help countries evaluate and consider other options for their cold chain, as well as appreciate the impact that various policies to minimize waste or lower cost might have on how many vials are opened and how many children are vaccinated.

Diagram of an optimal vaccine container.

It was a productive meeting, and I look forward to our joint commitment to find solutions to complicated issues and focus more on the system and how it impacts our ultimate results. Better decisions will lead to better product availability, guidance for manufacturers regarding country needs, better policies and more efficient systems. The process may be labor intensive at first, but the investment into getting it right and reframing how decisions are made can pay off multifold.

Lois Privor-Dumm, MIBS, is Director of Alliances and Information at IVAC. She oversees IVAC’s advocacy and communications efforts, large country programs, and special initiatives such as the primary container project.

By Dr. Sachiko Ozawa

Evidence on the value of vaccines is essential for donors and government officials to see what their investment in vaccines buys. This value isn’t only about the health impacts we tend to think of – such as lives saved, illnesses prevented, and disability averted from vaccines. Vaccines also bring about broader economic benefits. Families avoid treatment costs and parents do not have to take off from work to care for sick children. Children may also have fewer missed school days, succeed better in school, and take on higher-paying jobs to support the country’s economy. In short, vaccines are likely to bring much value beyond direct health impacts.

Sachiko Ozawa, PhD, MHS

Last week I participated on a value of vaccines panel at the GAVI Partners’ Forum that focused on just this idea. Raymond Hutubessy from the World Health Organization introduced the importance of valuing the full value of vaccines. I then presented the current evidence base including a recently published literature review from IVAC, which demonstrated that vaccines are cost-effective but highlighted the need to strengthen the economic data on vaccines. Till Barninghausen from the Harvard School of Public Health and Damian Walker from the Bill & Melinda Gates Foundation shared results from two case studies in South Africa and Bangladesh. These studies found that the measles vaccines can increase school attendance and improve school attainment (as measured by higher test scores), which may lead to a higher earning potential for these children.

We were pleased to have a truly engaged audience. The audience recognized that cost-benefit analyses that present the benefits of vaccines in dollar values are useful and needed, which is a contrast from the current norms to use cost-effectiveness data that assigns a dollar amount per DALY or disability-adjusted life year averted. An argument was made that just as interventions in other sectors could save lives, we need to present the benefits of health interventions in the same financial terms these sectors would use, in order to show the full return on investment. It was also noted that we are not done building the evidence base around the narrow benefits of vaccines. Therefore, a suggestion was made that we build economic evidence both at the narrow and broad levels concurrently. Another point made at the session was that many of these broad benefits may result not only because of vaccines, but because of a combination of health interventions that save lives and prevent illnesses. Audience members suggested looking into measuring the economic value of a package of interventions, or of a healthy child as a whole, in order to support efforts to advocate for investment in health vis-à-vis other sectors.

This successful panel and discussion led to an unexpected and truly exciting opportunity. Our panel was called upon by about 25 parliamentarians participating at the forum to give a separate presentation to this honorable group. This meant we could disseminate our work to the people who are actually advocating for vaccines in low- and middle-income countries. What an opportunity! We took to this occasion with enthusiasm and received feedback from the parliamentarians that confirmed they need evidence in dollar values to take to their ministers of finance. Many members of parliament in the room said they were glad to be armed with more evidence they can use to advocate for vaccines. We truly hope this type of engagement will continue with parliamentarians beyond this forum.

At IVAC we pride ourselves on being able to create, model and develop evidence that could be used in decision-making. Last week I witnessed that the evidence we develop indeed matters to audiences who use it to advocate for improvements in child health. Beyond the opportunity to share our evidence with parliamentarians and receive their feedback, I saw the economic evidence we developed put to use in advocacy materials such as an infographic created by the United Nations Foundation’s Shot@Life campaign.

One statement at the forum stuck with me: “Advocacy without evidence is just opinion.” I look forward to continuing to build the economic evidence that can be used by advocates – work that truly matters to saving children’s lives.

Sachiko Ozawa, PhD, MHS, is an Assistant Scientist with Johns Hopkins University Bloomberg School of Public Health and IVAC.

By Dr. Kate O'Brien

This week, IVAC staff have had the privilege to participate in the GAVI Alliance Partners’ Forum in Dar es Salaam, Tanzania. This could not be a more fitting choice of location, as a country that has shown remarkable leadership and commitment to vaccines for children. Yesterday (December 6th) marked the dual launch of rotavirus vaccine and pneumococcal conjugate vaccine in Tanzania, the second country to have undertaken such a dual launch (Ghana being the first).

The Partners’ Forum brings together in one place the truly remarkable range of partners that make up the Alliance including civil society organizations, UNICEF, WHO, GAVI-country representatives, donor country representatives, the Bill & Melinda Gates Foundation, vaccine manufacturers, the World Bank, the Pan American Health Organization (PAHO) and many others, coordinated in their efforts through the leadership of the Secretariat. IVAC, and numerous other technical and academic groups, are counted among these valued GAVI partners producing work that really does move the needle.

The theme of this Partners’ Forum is RISE, highlighting Results, Innovation, Sustainability and Equity – four themes that resonate for us at IVAC. I want to particularly focus on the results, without which there is nothing upon which to base innovation, nothing to sustain and nothing driving an insistence on equity.

Throughout this Forum we have seen the power of evidence to propel sound decision-making and commitments that are saving lives and reducing suffering around the world. We saw the power of pneumococcal conjugate vaccine disease impact data from Kenya where in just two years of vaccine use, vaccine type pneumococcal disease is becoming vanishingly rare. We also saw the compelling case for vaccines through the promise of over $150 billion of economic benefits gained over 10 years through improved health by vaccination. And we saw the reassurance of real-world performance and safety evaluations for rotavirus and pneumococcal vaccines in settings around the world where the vaccines are most needed.

Photo Credit: Excerpt from Shot at Life's Economic Value of Vaccination Infographic. Based on Decades of Vaccine Economics (DoVE) research from IVAC showing that increasing access to coverage with new and existing vaccines can yield substantial health and economic benefits (Stack, et al. Health Affairs - June 2011).

These results meaningfully strengthen the foundation of evidence on which these vaccines stand. Speaking for themselves, these data bring renewed energy, commitment and resolve that the extraordinary effort by hundreds of thousands of community health workers, nurses and doctors to get these vaccines into children, on time for every dose, will indeed deliver results.

IVAC is proud to have collaborated with various organizations, both in country and internationally, to generate the results highlighted above. These particular studies are a great example of how we all stand shoulder to shoulder with our partners, and our partners’ partners, to make vaccines real for children, families and communities. Through the GAVI Alliance we have had the opportunity to work in trusted collaboration with PATH, CDC, Aga Khan University, University of Witwatersrand, Norwegian Institute of Public Health, KEMRI Wellcome Trust, WHO, PAHO, MRC Gambia, South Africa’s National Institute of Communicable Disease, and many other institutions on projects, studies, evaluations, trainings, and assessments that are all delivering directly on our shared vaccine mission.

This Partners’ Forum has been a focused opportunity to see compelling results make a difference. It is really happening. As we contemplate what it will take to assure every child is not just vaccinated but fully vaccinated, I urge us all to lean forward together in this effort to ensure change happens.

We at IVAC are committed to Rising to the Challenge with all of you.

Kate O’Brien, MD, MPH is Acting Director of IVAC. A pediatric infectious disease physician, epidemiologist and vaccinologist, she previously served as Deputy Director of IVAC. She also serves as Associate Director of the Center for American Indian Health.